On 7 July 2012 the Italian Counsel of Ministry adopted and published in the Italian Official Journal (Gazzetta Ufficiale) law decree 95/2012 (the Decree) concerning revision of the expenditures borne by Italian administrations. In particular Article 15 of the Decree includes a number of provisions aimed at rationalizing and possibly reducing the expenses of the national healthcare system (NHS).
According to Italian law (i.e. Article 77 of the Italian Constitution) the Decree came into effect as law 135/2012 (the Law) 60 days later, on 15 August 2012.
The measures introduced by the Decree and confirmed, with amendments, by the law aim at obtaining an overall saving for the NHS equal to 4,7 billion Euros by 2015.
The most relevant provisions are the following.
Cut to the NHS funding (Art 15, par 22)
The funding of the NHS will be reduced by 900 million Euros in 2012, 1800 millions in 2013 and 2000 millions in 2014. Funding for 2015 has been reduced by 2100 millions. Allocation of the reduced funding shall be done in agreement between Regions and the public administration by 30 September 2012 for the present year and by the 30 November 2012 for 2013 and beyond. In case an agreement is not reached the allocation will be determined by the Government.
Medicinal products (Art 15, par 11)
For 2012 the discount that pharmaceutical companies and pharmacies must grant in favour of the NHS is increased.
However, the initial discount granted in accordance with the Decree has been reduced, (i) for pharmaceutical companies the original increase from 1.83% to 6.5% (for 2012) has become 4.1% (ii) for pharmacies the original increase from 1.82% to 3.65% has become 2.25%.
For the following years the NHS expenditure will be controlled/regulated by imposing caps on pharmaceutical territorial and hospital expenses.
The newly introduced cap for 2013 (i) for pharmaceutical territorial expenses originally decreased from 13.3% to 11,5% has been reduced to 13.1% for 2012 and then to 11.35% for 2013; (ii) for pharmaceutical hospital expenses originally decreased from 2.4% to 3.2% have been reduced to 3.5%.
In case of over-expenditure of pharmaceutical territorial expenses, there already is an obligation in place for pharmaceutical companies to pay back pro quota. In case of over-expenditure of pharmaceutical hospital expenses (as of today entirely borne by each Region) pharmaceutical companies shall bear 50% of said over-expenditure and pay back the relevant amount pro quota.
In order to limit pharmaceutical hospital expenditure company annual budgets have been introduced, including with regard expenses calculated essentially based on the type of products distributed (e.g. generics, originator).
The introduction of a new compensation system for wholesalers and pharmacies in January 2013 is to be established by Ministerial decree which is to be issued within 90 days from entry into force of the law and to be drafted in agreement with the Ministry of Economics, AIFA and relevant business associations.
Generics (Art 15, par 11bis)
The law provides that where patients are treated for a chronic disease for the first time or for new cases of a non-chronic disease, which can be treated with equivalent products, doctors are obliged to indicate in the relevant prescription the active principle to be used with no reference to a specific brand. Doctors are free however to indicate a specific brand and to oblige the pharmacist to not substitute the product where they expressly give reasons for this choice. Previous rules provided that doctors could prescribe either by indicating a brand or an active principle and that doctors might also expressly indicate that a brand product could not be substituted with a generics for specific clinical reasons (which however did not have to be – by law – indicated in the relevant prescription).
Goods and services other than medicinal products (Art 15, par 12, 13 and14)
The Decree provides a number of provisions aimed at limiting expenses concerning procurement of sanitary goods and services (other than medicinal products). A 5% cut of costs concerning public procurements already in place is anticipated (which does not apply to medicinal products). Such a reduction will apply immediately and will be effective until 31 December 2012 for medical devices and until the natural expiration of the relevant agreement for other products. In relation to medical devices, a maximum cap of expenditures borne by the NHS will be introduced from 2013.
Contracts already concluded with present prices exceeding 20% reference prices shall be renegotiated by the relevant public administration and, in case of disagreement, terminated by said public administration.
Medical devices (Art 15, par 13, lit f)
A maximum cap of expenditures borne by the NHS is fixed at 4.9% for 2013 and at 4.8% as of 2014.
Hospitals (Art 15, par 13, lit c)
A reduction of the bed to patient ratio (of up to 3.7 : 1.000) and a proportionate reduction of hospital personnel is anticipated by 31 December 2012 (originally the dead-line was 30 November 2012). By the same date, regions shall reduce hospitalization to 160 : 1.000 (25% of it as day hospital). A new regulation to be adopted by 28 February 2013 shall define new quality, structural, technological e quantitative standard of hospital care.
Private accredited centres and professional care assistance (Art 15, par 14 and 15)
The Decree has introduced and the law confirmed a reduction of expenses deriving from care assistance provided by private accredited centres and professionals.
Health Agreement – “Patto per la salute” (Art 15, par 12)
Reductions imposed in relation to goods, services, medical devices and private accredited centres and professional care assistance as of 2013 may vary in agreement with the regions and in line with the new “Patto per la Salute” 2013/2015 to be concluded by 31 July 2012.
Budgetary contain plans - “Piani di rientro” (Art 15, par 20 e 21)
Regions can extent “Piano di rientro” for 2013 in case the verification of the measures adopted is not positive. Criteria for verifying the objectives of the “Piano di rientro” have been better identified.
Other cases on the EU and National Life Sciences developments newsletter for October 2012